【R&D】Japan Regulatory Lead (JRL), Regulatory, 薬事統括部 RAオンコロジー領域部

仕事内容

■ 職務内容 / Job Description

Japan Regulatory Lead (JRL) is responsible for planning and execution of Japan regulatory strategy of the assigned products/projects

Providing strategic regulatory expertise for optimum market access of the products in Japan as a member of Japan project team and Global Regulatory Strategy Team(GRST)

Leading communication of the global regulatory strategy and its implication to Japan so that the context of regulatory input are properly understood by the governance bodies in GMeds, iMeds and MedI for their quality decisions through communication with GRST/Global regulatory execution team (GRET).

Preparing, updating, and implementing regulatory operational plans to deliver regulatory outcomes of the assigned products/projects.

Managing quality regulatory deliverables of the assigned products/projects throughout the product’s lifecycle.

JRL will also contributeto regulatory policy shaping within the TA by working closely with TA RAD and Regulatory Policy and Intelligence Department

JRL will work flexibly within and across the Therapeutic Areas to provide broad operational and/or strategic support to ensure regulatory deliverables

■ 応募資格（経験、資格等）/ Qualification (Experience & Skill etc.)

【経験 / Experience】

＜必須 / Mandatory＞

Relevant regulatory experience or experience elsewhere in Pharmaceutical industry

Cross-functionalproject team experience

Thorough knowledge of the drug development process

Written and verbal communication skills

Scientific knowledge sufficient to understand all aspects of regulatory issues

＜歓迎 / Nice to have＞

Getting drug/deviceapprovalsand supporting launch activities, such as a price negotiation, as a leading person

Drug development and regulatory affairs experience in outside of Japan

Working with external bodies, such as co-development companies and key opinion leaders, as a leading person.

Line management

【資格 / License】

＜必須 / Mandatory＞

Bachelor’s Degree in Science or related discipline

【能力 / Skill-set】

＜必須 / Mandatory＞

Project management skill

Customer focused

Communication and assertiveness

Understanding of the importance of Continuous Improvement

Knowledge Sharing

Team working

Ethics –overriding commitment to integrity and high standards in self

【語学 / Language】

＜必須 / Mandatory＞

英語 English：Business English (Speaking level 6 or above)

【キャリアレベル / Career Level】

D or E

【勤務地 / Work Location】

Osaka or Tokyo